Historically, CABG's (coronary artery bypass graft) have been hand sewn and the surgeon's skill and experience are truly tested in creating the arteriotomy, trimming the graft and placing the 20 or more sutures to create a patent anastomosis in vessels that are between one and four millimeters in diameter. Particular attention is paid to suture placement to (1) secure the intima to the vessel wall; (2) prevent the dislodgment of plaque or intimal flaps; (3) provide an intima-to-intima joint; (4) ensure that the flow channel proximal to the heel and toe portions of the joint remain open: and (5) make a leak-proof joint.
In practice, the heel and toe are the fixed points for the procedure and the side length of the anastomosis is adjusted to compensate for anatomical differences among patients. A disproportionate amount of the cardiovascular surgeon's skill and time is expended to accomplish the heel and toe of the anastomosis. For example, in a typical vascular graft, if the total length of the anastomotic joint is divided in thirds, the heel and toe portion represent about one-third of the length, but require about two-thirds of the time to complete. In the MIDCABG (compared to open) procedure, providing a patent anastomosis on a stabilized heart is more challenging due to the inherent motion of the vessels and the inherent difficulty and limited vision afforded by operating at the end of a stick. In addition, management of the heel and toe of an anastomosis is the more difficult and time-consuming portion of the entire procedure.
The literature is replete with a variety of types of fasteners (fittings, collars, stents, staples, clips, etc.) that can be used for tubular anastomosis. However, these fasteners have a number of undesirable characteristics such as being too large, being of fixed size or inflexible shape, being foreign body incompatible, having a tendency to create unacceptable flow disruption, and/or being difficult to use.
What is needed is a device that provides an improved system for creating a tubular anastomosis that is easier and more time efficient to use while not reducing the effectiveness or reliability of the procedure.